New "female Viagra®" Addyi has serious side effects

A treatment for female sexual dissatisfaction that had been rejected by the FDA in 2010 and 2014, was approved in August and will hit pharmacies this October. The drug Flibanserin, commonly known as Addyi, drew "cheering and high-fives" from proponents during its unexpected sanction. Others, like Liz Canner, producer of the 2011 film "Orgasm Inc," were left shaking their heads and saying "it's a sad day for science and women's health."

For years, only men had felt the benefits of sexually stimulating drugs like Viagra®, which averages around $2 billion in worldwide annual sales. The market for women has been largely untouched, although more than 50 million women also have trouble under the sheets.

"Female sexual dysfunction (FSD), which encompasses the inability to orgasm, is very common — as high as 43 percent, according to some surveys — and has been a topic of much debate and medical investigation lately. For some women, topical testosterone therapies or some oral medications can be helpful, but few medical treatments have solid evidence behind them."

There exists a couple of long held beliefs as to why female Viagra® has never been FDA approved. And two of those are actually, with little surprise, rearing their head with the introduction of Addyi.

First, some believe female Viagra® poses severe risks for women.

For example, in 2010 scientists introduced a female sexual dysfunction drug called Lybrido. Similar to Addyi, the drug intends to help women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD) by increasing lubrication and blood flow in the genitals and by stimulating her brain.

Critics were concerned with Lybrido and thought it might lead to "female excesses, crazed binges of infidelity and societal splintering." In other words, because Lybrido also affects her brain, it could make a woman more aggressive.

Similar fears exist with Addyi because it was originally produced as an anti-depressant in the early 1990s. The drug, while increasing blood flow to a woman's genitals also adjusts the balance of neurotransmitters in her brain in an attempt to make her more interested in having sex. Viagra®, on the other hand, only stimulates blood flow in male genitals.

"How do you make somebody want to have sex? How do you make someone want to go to work in the morning? I don't know how a pill does that, because there are so many aspects to desire," said Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City.

Feminist groups raised another, less conclusive reason female Viagra® hasn't made a dent in the market. These groups believe the FDA is gender-biased, and thus, repeatedly rejected Addyi because it believes women aren't supposed to need or want to have sex. Thy support their claim by pointing out there are currently 26 drugs marketed towards men with sexual dysfunction. But there are none for women.

Dr. Mary Jane Minkin, a clinical professor of obstetrics and gynecology at Yale University School of Medicine, refuted these claims, saying the lack of female Viagra® options have nothing to do with gender. Instead, they are likely due to a lack of research.

"The data they [the makers of Addyi] brought last time [to Congress]," said Minkin, "did not seem appropriate to lead to the approval of the drug."

And while the research recently brought to the FDA did persuade officials to pass Addyi, many serious health concerns still remain. We'll delve into those in a bit.

How did it get approved?

In 2010, the drug's sponsor Boehringer Ingelheim submitted its findings from its trial to the FDA. The administration, however, did not believe Ingelheim had proven the drug to significantly increase a woman's sexual desire and did not approve its application.

In 2015 Sprout Pharmaceuticals sponsored the drug instead and through their own studies went before the FDA to have Addyi approved.

The FDA then analyzed three, random double-blind trials that were conducted with close to 2,400 women over the course of 24 weeks. They all were an average age of 36 years old and had been diagnosed with hypoactive sexual disorder (HSDD). They provided some women a placebo and others with Addyi.

The women took a 100-mg dose of Addyi before they went to bed each night, and the effects of the drug were recorded. Women who had taken Addyi reported only a modest increase in sexual desire. However, it did help reduce stress that was brought on by low sexual desire. This made sense considering it was once used to reduce depression.

The FDA found Addyi caused scary side effects, such as nausea, dizziness, fatigue, sleepiness, insomnia and dry mouth. Other problems included an increased risk of hypotension, severely low blood pressure and loss of consciousness, especially if women take the drug with alcohol. These problems originally led the FDA to cast the pill aside in 2010 and again in 2014.

The other problem with Addyi is that it's long-term effects for taking it daily is unknown. According to a letter produced by Cynthia A. Pearson, Executive National Women's Health Network, "the sponsor [Sprout] was not able to provide any information on long-term safety because the trial was only 6 months long."

Although the National Women's Health Network urged the FDA to denounce the drug, the department eventually let it pass.